190376
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Core Antibody
体外诊断 检测试剂/试剂盒、血清学、病毒、乙型肝炎、核心抗体
Abbott GmbH & Co. KG·D·Hong Kong MDACS·Registered July 24, 2024
Device overview
- Risk class
- D
- Product code
- 17355
- State
- current
- Status
- N/A
- Product code detail
- 17355 IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Core Antibody
Manufacturer (製造商)
- Name
- Abbott GmbH & Co. KGAbbott Gmbh
- Country
- Germany德国
- Address
- Max-Planck-Ring 2, 65205 Wiesbaden, Germany马克斯-普朗克环 2, 65205 威斯巴登, 德国
Authorised representative (AR)
- Name
- Abbott Laboratories Limited美国雅培制药有限公司
- Phone
- 25668711, 98615786
Regulatory timeline
- Registration date
- July 24, 2024
- Expiry date
- November 25, 2029
Product models
Alinity i Anti-HBc II Reagent Kit (07P8722, 07P8732) \r\nAlinity i Anti-HBc II Calibrator (07P8701)\r\nAlinity i Anti-HBc II Control (07P8710)\r\n
Alinity i 抗 HBc II 试剂盒 (07P8722, 07P8732) \r\nAlinity i 抗 HBc II 校准品 (07P8701)\r\nAlinity i 抗 HBc II 对照品 (07P8710)\r\n
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Core Antibody. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Core Antibody
產品資訊： 体外诊断 检测试剂/试剂盒、血清学、病毒、乙型肝炎、核心抗体